The DEBRA Trial: De-escalating Breast Radiation After Lumpectomy for Low Risk, Estrogen Receptor Positive, Breast Cancer

This study is for women who meet the following criteria:

• have low-risk, early-stage breast cancer that is sensitive to hormone treatment
• have had a lumpectomy
• have an Oncotype Recurrence Score that is equal to or less than 18

If you decide to take part in this study and you have a small tumor and negative lymph nodes in your armpit but do not have an Oncotype DX Recurrence score, then some of the tissue left over from your breast surgery or when you were initially diagnosed with cancer will be sent to have an Oncotype DX Recurrence score done. If the test shows that your Oncotype DX Recurrence Score is equal to or less than 18 and you meet all other study requirements, then you can join the study.

This study will be checking to see if treatment with hormonal therapy alone is the same asthe usual treatment of radiation and hormonal therapy in women with low-risk, hormone-sensitive breast cancer who have had a lumpectomy.

If you decide to take part in the study, you will be randomly assigned to one of two possible study groups. You will either be given the usual treatment of receiving radiation to the breast and taking a hormonal medicine for at least five years, or you will be given the study treatment, only taking a hormonal medicine for at least five years.

The usual approach for patients who undergo lumpectomy and are not in a study is treatment with radiation therapy to the breast and hormonal medicine. Radiation therapy can be targeted at part or all of the breast and is delivered over 1-6 weeks. Your doctor can explain which breast radiation treatment method may be best for you. There are several hormonal medicines approved by the Food and Drug Administration (FDA) that are commonly used. Your doctor can explain which hormonal medicine may be best for you. For patients who get the usual approach for this cancer, about 98 out of 100 are cancer free after five years.

If you choose to take part in this study, there is a risk that:

• You may lose time at work or home and spend more time in the hospital or doctor’s office than usual.
• You may be asked sensitive or private questions which you normally do not discuss.
• The hormonal medicine alone may not be as good as the usual approach for your cancer at treating your cancer and preventing your cancer from returning.
• The breast radiation therapy and hormonal therapy used on this trial may cause side effects. The most common side effects of breast radiation therapy are reddening, tanning, or peeling of the skin; mild breast pain or tenderness; and tiredness. There may also be some side effects from the hormonal medicine, including hot flashes, flushing or night sweats, aching or pain in the joints, and vaginal dryness. Your doctor will review all of the potential side effects with you, though there may be some risks that the study doctors do not yet know about. It is important to tell your doctor about any side effects as soon as possible during the study so that they can be treated and so that potential adjustments to the hormonal drugs and/or radiation therapy can be made.

There is  evidence that the hormone medicine alone after lumpectomy is effective againstyour type of hormone sensitive cancer. It is not possible to know if, comparedto the usual approach, the study approach will extend your time withoutdisease. This study will give the study doctors information that may help cancerpatients omit radiation in the future.

Your doctor and study team will continue to follow your condition for a total of ten years, watching you to see if your breast cancer comes back. Over those ten years, they will check your condition at the following intervals:

• three months after starting the study
• after the last dose of radiation therapy (if you are in the group which receives radiation therapy)
• then every six months for the next two years
• after that, they will check your condition once a year for the next eight years 

These checks will be completed during visits to your study doctor.

No. Taking part in this study is voluntary. You are free to choose to participate or not to participate. If you choose to participate in this study, you are able to leave the study at any time. If you decide not to take part in this study, your doctor will discuss other treatment options with you.

You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your breast cancer. This includes:

• the costs of tests, exams, procedures, and medicines that you get during the study to monitor your safety and prevent and treat side effects.

• your insurance co-pays and deductibles.

Talk to your insurance provider and make sure that you understand what your insurance pays for and what it does not pay for if you take part in this clinical trial. Also, find out if you need approval from your plan before you can take part in the study.Ask your doctor or nurse for help finding the right person to talk to if you are unsure which costs will be billed to you or your insurance.You and /or your insurance plan normally will need to pay for the Oncotype DX Recurrence Score testing. Exact Sciences will cover the cost of this test for patients with very small tumors that do not have an Oncotype DX Recurrence Score.You will not be paid for taking part in this study.

Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information and/or information about your specimens from this study will be kept in a central database for research. Your name or contact information will not be put in the database.

There are organizations that may inspect your records. These organizations are required to make sure your information is kept private, unless required by law to provide information. Some of these organizations are:

• NRG Oncology and Exact Sciences, the company supporting the study now or in the future. This would include any organization helping the company with the study.
• The National Cancer Institute Central Institutional Review Board, which is a group of people who review the research with the goal of protecting the people who take part in the study.
• The FDA and the groups it works with to review research.
• The NCI and the groups it works with to review research, including the Cancer Trials Support Unit (CTSU).
• The NCI’s National Clinical Trials Network and the groups it works with to conduct research including the Imaging and Radiation Oncology Core (IROC).

Doctors and researchers conduct a clinical study, also called a “clinical trial,” to find better ways to prevent, diagnose, or treat an illness. NRG Oncology is supported by the National Cancer Institute (NCI) and runs clinical studies specifically for patients with cancer or to prevent cancer. Most clinical studies test something we know against something we don’t know. In all situations, these studies are strictly evaluated before they are allowed to be offered to any patient. The study is designed to answer the question that we do not know the answer to, so that current and future patients may have better treatments or information than what we currently have. There are different types of clinical studies that might be available for patients. For more information see “Types of Clinical Trials” and “Phases of Clinical Trials”.

Patients who volunteer to take part in a clinical study are followed closely by their health care professionals and members of the research team. For more information see “Research Team Members”.

Yes. They are exactly the same thing.

The care cancer doctors provide to cancer patients today is the direct result of clinical studies (also known as clinical trials) that were done in the past. Clinical studies give doctors and the treatment team information about what types of treatments work and what treatments do not work, in a number of different situations. Some studies focus on treating the cancer, others on preventing the cancer, and others on helping patients feel better or healthier during or after treatments. When you take part in a clinical study, you add to our knowledge about cancer and it may help improve cancer care for future patients. Clinical studies are available to patients with many types of cancer and at all stages of treatment. In some situations, the only way to get these new treatments is by joining a clinical study.

A clinical study may take place in many locations, such as:

physician offices

hospitals

clinics

A study is typically led by a principal investigator who is a doctor or other advanced health care professional. A clinical study is carried out by following a very specific plan known as the “protocol”. The protocol is designed so all patients in the study are treated as well as possible and in the same way. The protocol also provides rules for the doctors and clinical study staff to follow to keep patients safe and make sure the study is run in an ethical manner.

No, not at all. Participation in a clinical study is completely voluntary. For more information see “Deciding to Take Part in a Clinical Trial”. You are free to choose to participate or not to participate. If you choose to participate in a study, you may still decide to leave the study at any time. If you decide not to participate in a study, your doctor will discuss other treatment options with you. For more information see “Questions to Ask Your Doctor about Treatment Clinical Trials".

• You may choose to have the usual treatment approach (known as “standard of care”)
• You may choose to take part or learn more about a different study, if one is available
• You may choose not to be treated for cancer